US healthcare professionals Patient Information Important Safety Information Instructions for Use

For US consumers

GRANIX is a prescription medication given to people with certain types of cancer (non-myeloid malignancies) who are receiving chemotherapy that affects the bone marrow to decrease the length of time that certain white blood cells (neutrophils) are very low (severe neutropenia).

Important Safety Information: Do not take GRANIX if you have had a serious allergic reaction to filgrastim or pegfilgrastim products. Before you receive GRANIX, tell your healthcare provider about all of your medical conditions, including if you have a sickle cell disorder, have kidney problems, plan to have bone scans or tests, are pregnant or plan to become pregnant (it is not known if GRANIX will harm your unborn baby; you should not become pregnant during treatment with GRANIX), are breastfeeding or plan to breastfeed (it is not known if GRANIX passes into your breast milk).

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Teva Pharmaceuticals

41 Moores Road

Frazer, PA 19355 USA

1-610-344-0200

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Medical information

For healthcare professionals or patients with specific medical questions about GRANIX, please contact us at:

Teva Medical Information

1-800-896-5855

USMedInfo@tevapharm.com

Approved use of GRANIX

GRANIX is a prescription medication given to people with certain types of cancer (non-myeloid malignancies) who are receiving chemotherapy that affects the bone marrow to decrease the length of time that certain white blood cells (neutrophils) are very low (severe neutropenia).

It is not known if GRANIX is safe and effective in children.

Important Safety Information

Do not take GRANIX if you have had a serious allergic reaction to filgrastim or pegfligrastim products.

Before you receive GRANIX, tell your healthcare provider about all of your medical conditions, including if you:

  • have a sickle cell disorder
  • have kidney problems
  • plan to have bone scans or tests
  • are pregnant or plan to become pregnant. It is not known if GRANIX will harm your unborn baby. You should not become pregnant during treatment with GRANIX
  • are breastfeeding or plan to breastfeed. It is not known if GRANIX passes into your breast milk

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of GRANIX?

Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in your left upper stomach (abdomen)-area or your left shoulder during treatment with GRANIX.

A serious lung problem called acute respiratory distress syndrome (ARDS). Call your healthcare provider or get emergency medical help right away if you have shortness of breath with or without fever, trouble breathing, or a fast rate of breathing.

Serious Allergic Reactions. GRANIX can cause serious allergic reactions. These reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you have any of these symptoms, stop using GRANIX and call your healthcare provider or get emergency help right away.

Sickle cell crisis. You may have a serious sickle cell crisis if you have a sickle cell disorder and use GRANIX. Serious sickle cell crisis has happened in people with sickle cell disorder receiving filgrastim that has sometimes led to death. Call your healthcare provider right away if you have symptoms of sickle cell crisis such as pain or difficulty breathing.

Kidney injury (glomerulonephritis). GRANIX can cause kidney injury. Call your healthcare provider right away if you develop any of the following symptoms:

  • swelling of your face or ankles
  • blood in your urine or dark colored urine
  • you urinate less than usual

Capillary Leak Syndrome. GRANIX can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of the following symptoms:

  • swelling or puffiness and are urinating less than usual
  • trouble breathing
  • swelling of your stomach-area (abdomen) and feeling of fullness
  • dizziness or feeling faint
  • a general feeling of tiredness

Your healthcare provider may decrease your dose, temporarily stop, or permanently stop treatment with GRANIX if you have certain side effects. The most common side effect of GRANIX is bone pain.

Tell your healthcare provider right way if you have any signs of infection during treatment with GRANIX such as fever, redness, or swelling.

These are not all the possible side effects of GRANIX. For a complete list, ask your doctor or pharmacist.

Click here to access the Full Prescribing Information for GRANIX.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit fda.gov/medwatch, or call 1-800-FDA-1088.